FDA 510(k) Application Details - K021242

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K021242
Device Name Alloy, Gold-Based Noble Metal
Applicant WIELAND DENTAL + TECHNIK GMBH & CO. KG
SCHWENNINGER STRABE 13
PFORZHEIM D-75179 DE
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Contact GERHARD POLZER
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 04/19/2002
Decision Date 05/16/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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